Regulatory Affairs Specialist
Are you looking to join an award-winning pharmaceutical company? Morningside Healthcare Ltd are excited to announce that we are currently looking to recruit a Regulatory Affairs Specialist to join our team in our new modern offices.
Duties and Responsibilities (including but not limited to):
- Experience in Formulation Regulatory, specifically in the EU applications MRP/DCP
- Quality review in CTD / eCTD format as per EU guidelines
- Compilation of dossiers for EU timely submission
- Close interaction with query response and coordination
- Formulating regulatory strategy for filing various products in the EU
- Compliance from regulatory point of view for audits and response.
- Strategic planning and execution of the International Regulatory Audits ( MHRA and other EU agencies)
- Experience in Quality Systems and implementation
- Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
- Implement QA systems and generate SOPs
- Close interaction with contract manufacturers both in and outside the EU
- Familiarity with readability testing would be helpful.
- Ability to work both independently and within a team structure;
- Proven ability to lead, influence and motivate colleagues and external partners;
- Good knowledge of guidelines from EMEA
- Good knowledge on tech transfer
- Strong planning, presentation and interpersonal skills;
- Strong work ethic, self-motivation, dedication and results orientation;
- Significant working knowledge of the pharmaceutical product development process (e.g., regulatory requirements, GMP, clinical strategies, drug delivery etc.);
- Understanding of the role of drug delivery in the pharmaceutical marketplace, in both scientific and business context (e.g., market exclusivity requirements, role of IP in life cycle management is a plus.
- Possession of first rate written and verbal communication skills.
- Demonstrate good working knowledge of IT systems.
- Ability to work to strict deadlines under pressure.
- Extensive Relevant Regulatory Affairs experience
- A strong technical background educated to degree level (or equivalent) in one of the life sciences.
28 days holiday (including public holidays)
Training and development
Staff discount Childcare voucher scheme